About the RoleThe Associate Director, Analytical Development (Biologics) will lead analytical development activities supporting biologics programs from preclinical development through clinical execution. This role will oversee method development, validation, transfer, stability programs, and external laboratory activities, while ensuring analytical strategies are aligned with program needs, phase-appropriate CMC development, and regulatory expectations.
Key Responsibilities- Lead the development, qualification, validation, and transfer of analytical methods across the product lifecycle for biologics programs.
- Support the selection and oversight of contract development and manufacturing organizations, and contract laboratories.
- Provide technical oversight for analytical methods supporting reference standards, starting materials, intermediates, release testing, stability testing, drug substance, and drug product.
- Manage analytical activities performed by external contract laboratories, ensuring scientific rigor, technical alignment, and compliance with applicable quality standards.
- Develop and implement analytical strategies appropriate for each stage of CMC development and consistent with evolving regulatory expectations.
- Author and provide technical review of relevant CMC sections for regulatory submissions, including INDs, IMPDs, BLAs, MAAs, and related filings.
- Design and manage non-GMP and cGMP stability programs for drug substance and drug product batches, providing scientific guidance to support shelf-life and expiry dating recommendations.
- Partner cross-functionally with Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, and external partners to ensure analytical plans are integrated with overall program objectives.
- Provide analytical expertise in support of out-of-specification results, deviations, non-conformance investigations, root cause analyses, and CAPA development.
- Serve as a key member of the CMC and Technical Operations team, contributing to cross-functional execution, continuous improvement, and a strong quality culture.
Qualifications- PhD in analytical chemistry or related discipline with more than 8 years of industry experience or BS/MS degree with more than 15 years industry experience
- Demonstrated experience in analytical development, method validation, method transfer, and molecular stability management within a regulated biopharmaceutical or pharmaceutical environment.
- Strong working knowledge of biologics CMC development, including complex modalities such as multi-specifics, as well as cGMP expectations, quality systems, and regulatory submission requirements.
- Experience managing external consultants, contract laboratories, CMOs, or CDMOs, with a proven ability to drive technical alignment across internal and external stakeholders.
- Experience supporting biologics, protein therapeutics, or other complex modalities from early development through clinical-stage execution.
- Track record of authoring or reviewing CMC content for IND, IMPD, BLA, MAA, or related regulatory submissions.
- Hands-on experience with HPLC, UHPLC, and LC-MS, including SEC, RP, and IEX chromatography. Experience with drug product assays, stability testing, formulation-related analytical methods, such as CE-SDS, icIEF, binding and potency assays, and impurity/residual testing, including HCP, DNA, and residual Protein A, is preferred.
Success Profile- The successful candidate will be a collaborative and scientifically rigorous leader who balances strategic thinking with hands-on technical problem solving. This individual will communicate effectively across functions, manage external partners with accountability, and help deliver high-quality CMC outcomes in a fast-paced development environment.
CompensationWe offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $172,000 - $215,000 annually; however, the base pay offered will vary depending on the market, job-related knowledge, skills and capabilities, and experience.
